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510(k) K760834

ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) by I M, Inc. — Product Code GMH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1976
Date Received
October 13, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Positive Control, Coccidioides Immitis
Device Class
Class II
Regulation Number
866.3135
Review Panel
MI
Submission Type

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  • K871495 — BANDAGES CATALOG NUMBER: 101 TO 220 (May 8, 1987)
  • K863785 — MAKLER CATHETER (December 11, 1986)
  • K854155 — STERILE SALINE SOLUTION (December 10, 1985)
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  • K853288 — FEEDING UNITS & TUBES (October 4, 1985)

Other clearances for product code GMH

  • K792684 — COCCIDIOIDES IMMITIS, ANTISERUM, (January 17, 1980)
  • K792688 — COCCIDIOIDES IMMITIS, ANTISERUM (January 17, 1980)
  • K792717 — COCCIDIOIDES IMMITIS, ANTISERUM POS. (January 17, 1980)
  • K791388 — ANTI-COCCIDIOIDES SERUM #CF10028X (August 16, 1979)